The Impact of Steroid Eluting Leads on Long Term Pacing in the Atrium and Ventricle

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1 EU.J.CE :10-15 by EBM The Impact of Steroid Eluting Leads on Long Term acing in the Atrium and Ventricle. SUTTON, and S. GUNEI Cardiac Department, Westminster Hospital, London, United Kingdom Summary Steroid eluting leads introduced in 1983have been shown in a series of 51 atrial and 73 ventricular leads (Medtronic4503and 4003)to offer no significantbenefitin terms of sensingor pacingin eitherchamber at implant. All leadsweretestednon-invasivelyat follow-up usingthe patients' implantedgenerator (acesetter283, 285, BiotronikDiplos 04, OS, Medtronic 7005).In shortterm follow-up significantly larger waves were seen 3.16 ± 2.16 vs 1.97 ± 0.97mV in comparisons madewithpresentlyavailable Medtronicstandardatrial leads. Both shortand long term atrial thresholds were highly significantly improved 1.10 ± 0.55 vs 1.65 ± 0.94 V and 0.93 ± 0.09 vs 1.07 ± 0.28 V respectively. Short, medium and long term ventricular thresholds were also were significantly improved 0.90 ± OvsO.96 ± 0.13V, 0.91 ± 0.07vs 1.19 ± 0.47Vand 0.97 ± 0.2 vs 1.07 ± 0.29V. Existence of sinus node disease does not appear to influence atrial sensing in the short and medium term. In conclusion, the addition of steroid-elution to electrode design is an important advance in pacing technology and offers the possibility of safe long term pacing at 2.5 V output or even lower and permits maintenance of wave detection in the short and medium term which is the period of greatest atrial sensing problems. Key words: atrial pacing, ventricular pacing, steroid-eluting leads, sensing, threshold Introduction When an electrode is implanted in the endocardium of the right atriumor rightventriclean inflammatory process evolves. In electrical terms this is translated into a rise of stimulation threshold, typically by %1, and a less pronouncedfall in or wave values-a It is reasonable to suppose that steroids will influence this phenomenon in a favourable manner. Indeed, whenthe threshold rise is pronounced and progressive leading to loss of pacing, a condition known as exit block, systemic steroids have been shown to be effective in some patientse.>, In Stokes et al.6,7, reported encouraging results indicating significant reduction in the post-implant thresholdrise by useof steroid in the electrode itself. The principle described involved the impregnation of the electrode with dexamethasone < 1 mg as its sodium phosphate salt which "leaks" out into the surrounding tissue slowly, possibly over more than Address for reprints: ichard Sutton, DSc Med C FACC FESC, Cardiac Department, Westminster Hospital, Horseferry oad, UK-London, SWI 2 A. eceived February 23, 1991; accepted: March 21, years 7,S. Thus, the systemic dose can be considered negligible. A real reduction in peri-electrode fibrous tissue has been documented". Since clinical introduction many reports of efficacy have been made. However, the majority of these reports have beenin abstractform resultingin, perhaps,less attention being given to the potential clinical value of these leads. Furthermore many countries'drug and deviceregulationbodieshaveconsidered these leads to be drugs rather than devices. Despite the fact that dexamethasone has been available for many years as an oral medication in these countries, the clinical introduction of steroid-eluting leads has been slowed down by regulatory authorities. The value of steroid-eluting leads was immediately demonstrable in reduction of the post-implant threshold rise in dogs6,7 and in manl'ul. Many subsequent reports served to emphasise the benefit in terms of stimulation threshold of the first generation of leads both in the ventricle and in the atrium I2,13. It was then established that the dexamethasone in the electrode was the active agent notably by a double- 10 Vol. 1, No.1, 1991

2 EU.J.CE.. Sutton et al.: Steroid Leads blind study of identical leads with the exception that oneof the groups of 10had steroid impregnationand the other did not 14. Thus electrode composition and geometry were eliminated as contributory factors to the good results. esults of the second generation of steroidleads havenowbeenpublished witha further improvement in threshold behaviour 15,16. These offera combinationof steroid-elution withimproved electrode surface and geometry. Manyof the above reportsmade mentionof adequate sensing characteristics of steroid-eluting leads but wavesensinghadpresented few clinical problemsin the immediate years before introduction of these leads and consequently little attention was focused on this aspect. More recently, steroid-eluting leads havebeen shown to provideimproved sensing in the atrium where clinical problems still exist with conventional leadst/-u'. Few of the reports presented any long term data concerning stimulation threshold or sensing. Other approaches to drug elution from the electrode have been made. 'In one a dexamethasone collar around the electrode is used with encouraging results in sheepl'', In another approach mannitol has been the drug of choice which is eluted much more rapidly offering some acute benefit-". The steroid eluting principle is now being applied to screw-in electrodes, initially epicardial-] and development is in progress for endocardial use. Bipolar steroid leads are also being Introduced-c. atient and Methods Our own experience of unipolar steroid-eluting leads consists of 124 leads of which 73 were implanted in the right ventricle (Medtronic 4003) and 51 in the right atrium (Medtronic 4503) over a period between 1983 and May Implantation data were collected with a Medtronic acemaker System Analyser initially 5309 later Follow-up data were collected by outpatient programming of the implanted generators: acesetteraf 283and 285,Biotronik Diplos 04 and 05, Medtronic Symbios This series of steroid leads has been drawn from a larger pool of leads. Selection was made on the basis of the implanted generatorallowing accurate followup threshold and sensing data. The total experience of 4503 leads is 115 and of 4003 leads 129. Almost no complications have been seen. One displacement took place among the 4503leads (0.9%) and no other complication was observed. In the 4003 series no complication occurred. Two patients (4%) of the study group of lead s have developed chronic atrial fibrillation precluding further measurements. Statistics Standard deviations are given in all cases. Comparisons are by paired students t test. esults The results are given in Tables 1-V. Steroid-eluting leads were chosen by generator type (see above) in the series and not selected specifically for patients with exit block. A comparative series of modern non-steroid eluting leads was selected from our database in order to give follow-up comparison according to pacemaker types. The equivalent nonsteroid leads from Medtronic are 4511 for atrial and 4011 for ventricular usc. The results of these leads implantedoverthe same period are givenin Table II. Table I: Implant data for 124 steroid-eluting leads ± ± ± ± 0.56 pul e wid th wave amplitud e lew rate n = 49 + n = 65 o n = 61 ± one standa rd de viation Table II: Implant data for non-steroid leads. V (W 0.5 ms) I (rna) (W 0.5 ms) S (VIs ) 0.55 ± ± ± ± 0.54 W = pulse wid th wave amplitude wa ve amplitud e S slew rate ± On e standard deviation Ventricular (Medtronic 4503) (Medtronic 4003) n =51 n = ± ± ± ± Ven tricular (Medtro nic 4511) (Medtro nic 4011) n =41 n = ± ± ± ± 1.06 Vol. 1, No.1,

3 . Sutton et al.: Steroid Leads EU.J.CE. Table III a: Follow-up data from steroid leads and acesetter generators. v (W 0.5 ms) V (W 0.5 m s) V(WO.5 ms) Imp edan ce (Ohms) Imped anc e (Ohms) Imp ed ance (Ohms) n = 25 n = 24 n = 20 n =25 n =22 n = 11 n = 23 n = 23 n = 18 (Medtronic 4503) 1.10 ± ± ± ± ± ± ± ± ± Ven tricular (Medtronic 4003) n =31 n = 31 n =23 n =29 n =26 n = 15 n = 30 n = 30 n = ± ± ± ± ± ± ± ± ± W pul e width wave am plitude wa ve amplitude ± 1. s tandard deviation on e week 6.73 ± 0.95 months for atrial leads and 9.54 ± 7.74 months for ventricular leads Table III b: Follow-up data from steroid leads and Biotronik generators. WT (2.5,v) ms / (mv) W WT = = = Ventricular (Medtronic 4503) (Medtronic 4003) n = ± 0.03 n = ± /52 n = ± 0.04 n = ± 0.11 fina l n = ± 0.06 n = ± 0.09 n = ± 0.48 n = ± /52 n = ± 0.31 n = ± 0.76 fina l n = ± 0.44 n = ±O pulse wid th wave amplitude pulse wid th threshold 6.45 ± 0.82 months for atrial lead s and ± mont hs for ventricular leads Table III c: Follow-up data from steroid leads and Medtronic generators. /(mv) W WT = 4/52 = = Ventricular (Medtronic 4503) (Medtronic 4003) n = ± 0.03 n = ± 0.04 n = ± 0.05 n = ± 0.03 fina l n = ± 0.04 n = ± 0.04 n = ± 0.82 n = ± 1.20 n = ± 0.61 n= ± 1.21 n = ± 0.63 n =5 4.5 ± 1.12 pulse wid th wave amplitude wave am plitude pulse wid th threshold 6.2 ± 0.45 months for atria l lead s and ± mon ths for ventricular leads No significant differences exist between any of the implant parameters for atrial or ventricular leads. The results of both the steroid and the non-steroid leads compare favourably with data on older leads from this Iaboratory-f with the exception of Medtro- nic 6971 in the ventricle and Medtronic 6957 in the atrium where threshold and sensing characteristics are very similar to steroid leads. The follow up data is presented for each generator type as threshold and sensitivity measurements are 12 Vol. 1, No.1, 1991

4 EU.J.CE.. Sutton et al.: Steroid Leads Table IVa: Follow-up data from non-steroid leads and acesetter generators. Ven tricular l edtronic 45W l edt ronic 4003) V (W O.5 m ) n = ± 0.94 H n = ± 0.13 H V (W 0.5 m ) n = ± 0.65 H n = ± 0.47 V (W 0.5 m ) fina l n = ± 0.2 H n = ± 0.29 / (mv) n = ± O. 6 n = ± 2.84 / (rnv) n = ± 0.97 n = ± 3.1 / (mv) n = ± 1.17 n = ± 2. 5 Imp ed ance (Ohm ) n = ± n = ± Impedance (Ohm) n = ± 44.0 n = ± 46.5 Imped an ce (Ohm ) n = ± n = ± H W 4/52 ± = p < 0.05 ) in compari on with stero id leads p < 0.01 ) ee Table lila pul e width wave amplitude ± 2.05 months for atrial lead and ± 3.04 months for ventricular lead on e standard deviation Table IV b: Follow-up data from non-steroid lead s and Biotronik generators. (Medtronic 4511) Ventricular (Medtronic 4011) / (mv) / (mv) / (mv) 4/52 n = 16 n = 16 n = 13 n =15 n = 11 n = ± ± 0.09 H 0.19 ± ± ± 0.63 H 1.07 ± 0,48 n = 27 n =27 n =26 n =15 n = 11 n = ± ± ± ± ± ± 0 p < 0.05 } in compa riso n with ste roid leads see Tabl e lilb H p< O.OI WT = pulse wid th thr eshold wave amplitu de 7.8 ± 4.15 mon ths for atrial leads and ± 7.95 months for ventricular lead s ± one stand ard de via tion Table IV c: Follow-up data from non-steroid leads and Medtronic generators. WT 4/52 ± Ventricular (Medtronic 4011) n = ± /52 n = ± 0.05 H fina l n = ± 0.02 / (mv) n = lo 4.25±1.14 / (mv) n = ± 1.54 / (mv) fina l n = ± 1.12 data from 4511 leads was unavailable as the older active fixation lead Medtronic 6957 was used. H p < 0.01 in compariso n with steroid lead s see Table III c pulse width threshold wave amplitude ± 6.63 months one sta nda rd deviation Table V: wave amplitude in sinus node disease (SND). All leads n = 92 All Leads n =92 (mv) Steroid Leads n =51 (mv) S D n = ± 1.59 S D n = ± 1.78 on Steroid Leads n =41 5 D n =15 (mv) 3.53 ± 1.32 wave amplitude ± one standard deviation 5 D sinus node disease OS D (n = 61) 3.75 ± 1.53 j 05 D (n = 35) 3.88 ± D (n =26) 3.56 ± 1.22 Vol.1, No.1,

5 . Sutton et al.: Steroid Leads EU.J.CE. determined by the programmable characteristics of each of the generators concerned (see Tables IlIa, b and c). These results indicate that no significant threshold rise was seen and adequate electrograms were available for sensing in both chambers with steroid leads in thefollow-up period. TablesIVa, band cillustrate the comparative follow-up data from non-steroid leads. Thus statistical comparisons between steroid and non-steroid leads in follow-up reveal significantly improved atrial thresholds both early and late with the use of steroid when the implanted generator permits measurement at the low values experienced. wave amplitude is also significantly improved in the early follow-up phase but not in the long term, although the numbers available for comparison at this stage are small. Early and late ventricular thresholds also show improvement with steroid leads, again this depends on the ability of the implanted unit to measure to these low values. It has been alleged 24 that sinus node disease is associated with low wave amplitude at implant. On theoretical grounds this might be expected. The theory was tested in this series. In a total of 92 leads no significant differences were found even when steroid leads versus non-steroid leads were examined (TableV). Sinusnodediseasein thesecases wasconsidered to exist when at least one and usually two or more of the following criteria were met: persistent sinus bradycardia < 60 bpm, chronotropic incompetence on exercise < 120 bpm, sinus arrest, sinoatrial block, escape atrial tachyarrhythmias, prolonged corrected sinus node recovery time < 550 ms. Discussion The resultspresentedserveto emphasisetheeffect of steroid leads on thresholds in the ventricle that have previously been publishedl'u! and a similar effect is seen in the atrium 12,13. The electrodegeometry of the steroid leads 4503 and 4003 differs from the 'target tip' of the 4511 and 4011 and the two features later have been combined in the second generation of steroid leads 15,16. Nevertheless a comparison between theselead typesis justifiedas they are bothin current production. Comparisonof steroid and non-steroid leads at acute implantation shows no difference in any parameter. Significantdifferences showthemselves at follow-up where atrial thresholds are lower when measured by acesetter and Biotronik pacemaker types, particularly at post implant, but also in the long term (acesetter). Long termatrial threshold is lower with steroid leads whenmeasured using a acesetter pacemaker. Short and long term benefits are seen in the ventricular threshold again only when the sophistication of the implanted pacemaker is sufficient to detect it. Some previous reports 14,25,26 have used special pacemakers with a 1.5 V setting which allowed better discrimination of these low thresholds. Had such units been used routinely in this series, differences in long term thresholds may have beenobvious. The clinical significanceof chronicvoltagethreshold differences of 0.1 V mustbe called into question. However, the marginal improvement offered bysteroid leads adds to clinical confidence in using low chronic pacemaker outputs. The clear implicationof theseand previouslypublished data is that steroid leads offer an appreciable benefit in threshold in the short and long term over other electrode designs and some benefit over contemporary nonsteroid designs. No differences were detected in the atria or the ventricle in the evolution of impedance between steroid and nonsteroid leads. This parameter could only be tested with acesetter generators. Withrespect to sensing an enhancedability to sense waves in the first few weeks after implant has been demonstrated using steroid leads with both pacemaker types. (acesetter and Biotronik) where comparison could be made. In this situation benefits of mV areof real clinical significancewithmaintained atrial sensing and avoidance of reversion to ventricular only pacing which could be symptomatic. Achievements in electrodedesignhavenowbrought us to consider as standard, pulse generators with 2.5 V output which allows discontinuation of the use of a voltage doubler and its associated current consumption. This advance in lead designs allows us to consider, safely, smaller generators without compromise in life expectancy. Furthermore, this development allows us the possibility of widespread use of more complex and current consuming systems such as DDD pacemakers. A combination of the improved electrode geometry and steroid elution 15,16 will, after further testing, be anticipated to show even lower chronic thresholds and possibly better chronic sensing-". This may offer solutions to 14 Vol.1, No.1, 1991

6 EU.J.CE.. Sutton et al.: Steroid Leads some of today's present pacing problems, notably atrial sensing. Bipolar configurations are only now being made available with steroid eluting electrodes but performance in trials seems similar to unipolar versions-e. This may also allow better atrial sensing as sensitivity can be safely programmed to high values without concern about electromyographic detection resulting in false inhibition and triggering. The theoretical concept that sinus node disease is associated with lower wave amplitudes has not been substantiated in this series where 92 leads have been assessed. It therefore seems unlikely that sinus node disease may be expected to be a major factor either in the short or medium term, where atrial sensing is concerned. In conclusion, steroid leads offer a prospect of safe lowoutput pacing in atrium and ventricle in the long term and improved short term atrial sensing. eferences 1 Davies JG, Sowton GE: Electrical threshold of the human heart. Br Heart J 1966; 28: Breivik K, Ohm O-J, Engedal H: Long-term comparisons of unipolar and bipolar pacing and sensing, using a multiprogrammable pacemaker system. ACE 1983; 6: Kruse I, yden L, Ydse B: A new lead for transvenous atrial pacing and sensing. Clinical and electrophysiological experiences. ACE 1980; 3: reston TA, Judge D: Alteration of pacemaker thresholdby drugandphysiologicalfactors. AnnN YAcadSci 1969; Beanlands DS, Akyurekli Y, Keon WJ: rednisolone in the management of exit block. In Meere CE: roceedings of the VIth World Symposium on Cardiac acing. Montreal, Canada Chp Stokes KB,Graf JE, Wiebusch WA: Drug-eluting electrodes - improved pacemaker performance. roceedings of 4th Annual Conference IEEE Frontiers of Engineering in Health Care 1982, Stokes KB, Bornzin GA, Wiebusch WA: A steroid-eluting,low threshold, low polarizing electrode. In K Steinbach, D Glogar, A Laszkovics, W Scheilbelhofer, H Weber (ed): Cardiac acing, Darmstadt, Steinkopff Verlag, 1983; Stokes K: Controlled release of steroid to enhance pacemaker performance (review). roceedings of 13th AnnualMeetingof thesocietyfor Biomaterials. 1987; adovskyas, Van VleetJF, Stokes KB,TackerJr WA: aired comparisons of steroid-eluting and non-steroid endocardial pacemaker leads in dogs: electrical performance and morphological alterations. ACE 1988; 11: Gordon S, Timmis GC, Westveer DC, Stewart], Stokes K, Helland J: A new low threshold steroid-eluting pacing lead (abstract). ACE 1983; 6:A arsonnet V, Werres : Clinical experience with a porous-tip steroid-loaded ventricular pacing electrode (abstract). ACE 1983; 6: Kruse 1M, Terpstra B: Acute and long-term atrial and ventricular stimulation thresholds with a steroid-eluting electrode. ACE 1985; 8: Anon: Capsure leads tested in nearly four years of clinical study. Medtronic News, Winter ; Mond H, Stokes K, Helland J, Grigg L, Kertes, ate B, Hunt D: The porous titanium steroid eluting electrode: a double-blind study assessing the stimulation threshold effects of steroid. ACE 1988; 11: Schall horn, Oleson K: Multicenter clinical experience with an improved steroid-eluting pacemaker lead (abstract). ACE 1988; 11: Heineman F, Schallhorn, Helland J: Clinical comparison of available "low threshold" leads (abstract). Eur Heart J 1988; 9:Abstract Supplement 1: Steinhaus D-M, Foley LM: sensing: a continuing problem? (abstract) ACE 1988; 11: Iesaka,Y, Aonuma K, Fujwara H: Long-term improvement of atrial pacing threshold and sensitivity with steroid tip leads: a comparative study between steroid and target tip leads (abstract). ACE 1988; 11: Brewer G, Mathivanar, Skalsky M, Anderson N: Composite electrode tips containing externally placed drug releasing collars. ACE 1988; 11: Ormerod D, Walgren S, BerglundJ, HeilJr : Design and evaluation of a low threshold porous tip lead with a mannitol coated screw-in tip ('sweet tip') (abstract). ACE 1988; 11: Stokes KB: reliminary studies on a new steroid-eluting epicardial electrode. ACE 1988; 11: abson JL, Bucher D, arrott JCW, Williams TM, Church T: Steroid-eluting electrode, bipolar threshold performance (abstract). ACE 1987; 10: errins EJ, Sutton, Kalebic B, ichards L, Morley C, Terpstra B: Modern atrial and ventricular leads for permanent cardiac pacing. Br Heart J 1981; 46: Oseroff 0, Klementowicz, Andrews C, Benedek M, Bohm A, Furman S: Indications for permanent mode change during DDD pacing (abstract). ACE 1987; 10: Stojanovic, Djordjevic M, Velimirovic D, Kocovic D, avlovic S: Four-year experience with steroid-eluting electrodes (abstract). ACE 1989; 12: Mond H, StrathmoreN, Hunt, HuntD: The steroidlead: comparison with conventional leads of long-term stimulation threshold data (abstract). ACE 1989; 12: irzada F, Muschitto LJ, DiOrio D: Clinical experience with steroid eluting electrode (abstract). ACE 1988; 11: Cuddy TE, obson JL, Bucher D, arrott JC, Church T: A comparison of threshold performance in bipolar and unipolar steroid-eluting electrodes (abstract). ACE 1987; 10:435. Vol. 1, No.1,

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